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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because a pre-natal developmental toxicity study is available
Cross-reference
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
developmental toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read-across from an analogue substance for which a guideline study (Klimish 1) is available.
Reason / purpose for cross-reference:
read-across source
Principles of method if other than guideline:
Read-across approach from data on an analogue substance.
Limit test:
no
Key result
Dose descriptor:
NOEL
Remarks:
Maternal toxicity
Effect level:
1 000 mg/kg bw (total dose)
Based on:
test mat.
Basis for effect level:
other: No adverse effects observed at any dose tested.
Remarks on result:
other: Based on a read across from an analogue substance.
Key result
Abnormalities:
no effects observed
Key result
Dose descriptor:
NOEL
Remarks:
Developmental toxicity
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No adverse effects observed at any dose tested.
Remarks on result:
other: Based on a read-across from an analogue substance
Key result
Abnormalities:
no effects observed
Key result
Developmental effects observed:
no
Conclusions:
Based on the read-across approach, the NOEL for pre-natal developmental toxity by oral route in rats was determined to be 1000 mg/kg bw/day.
Executive summary:

Based on experimental results obtained in a study according to OECD 414 on the analogue substance FB220 where the test item did not produce developmental and/or maternal toxicity, the read-across approach is applied and the NOEL for pre-natal developmental toxity by oral route in rats for the subtance P-0310 was determined to be 1000 mg/kg bw/day.

Data source

Materials and methods

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion